FDA Approval in CRC, Priority Review in HCC, Encouraging Data in Myeloma Trial, and More

Gina Columbus

Published: Friday, Jul 13, 2018

Today-

An FDA approval in colorectal cancer, a priority review in hepatocellular carcinoma, encouraging findings in a multiple myeloma trial, and disappointing results in studies of diffuse large B-cell lymphoma and non-Hodgkin lymphoma.

Welcome to OncLive News Network! I'm Gina Columbus.

The FDA granted an accelerated approval to the combination of nivolumab and ipilimumab for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer following progression on a fluoropyrimidine, oxaliplatin, and irinotecan.

The decision is based on data from a cohort of 119 patients with MSI-H or dMMR mCRC treated with the combination in the phase II CheckMate-142 study. In this cohort, 82 patients received prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and the overall response rate was 46% among these patients.

Among the 38 responders, there were 3 complete responses and 35 partial responses. The median duration of response was not reached.

Among all 119 patients, the ORR was 49%. Among the 58 responders in the overall population, there were 5 CRs and 53 PRs. The median DOR was not reached, with 83% of responders having a response greater than or equal to 6 months and 19% having a response more than 12 months. Fifty-one of the 58 responses were ongoing at the data cutoff.

The accelerated approval of nivolumab/ipilimumab in this setting is contingent upon results from a confirmatory trial.

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The FDA has granted a priority review designation to a supplemental biologics license application for pembrolizumab for previously treated patients with advanced hepatocellular carcinoma.

The application is based on data from the phase II KEYNOTE-224 trial, in which single-agent pembrolizumab induced an overall response rate of 17% among 104 patients with advanced HCC who were previously treated with sorafenib. Among the 18 patients who responded, there was 1 complete response and 17 partial responses. Additionally, 46 patients had stable disease, 34 had progressive disease, and 6 patients were not evaluable.

Progressive disease and adverse events were found to be the most frequent cause of discontinuation with pembrolizumab. Post-progression therapy included cabozantinib in 1 patient and regorafenib in 20 patients.

Under the Prescription Drug User Fee Act, the FDA is scheduled to make a decision on the application by November 9, 2018.

In multiple myeloma, ixazomib was found to improve progression-free survival versus placebo as a maintenance therapy in adult patients who responded to high-dose therapy and autologous stem cell transplant, according to data from the phase III TOURMALINE-MM3 study.

Takeda Pharmaceutical Company, the manufacturer of the proteasome inhibitor, did not provide any specific data from the trial, but plans to submit the results for presentation at the 2018 ASH Annual Meeting.

In its press release, Takeda reported that there were no new safety signals with maintenance ixazomib, and toxicities were consistent with data from earlier studies of ixazomib monotherapy.

The FDA approved ixazomib in November 2015 for use in combination with lenalidomide and dexamethasone as a treatment for patients with multiple myeloma who have received at least 1 prior therapy. The decision was based on data from the phase III TOURMALINE-MM1 trial, which showed that adding ixazomib to lenalidomide and dexamethasone reduced the risk of disease progression or death by 26% versus lenalidomide and dexamethasone alone for patients with relapsed/refractory disease.

The PIX306 study enrolled 312 previously treated patients who received R-CHOP or equivalent treatment and relapsed. Patients were not eligible for stem cell transplant.

Beyond the primary PFS endpoint, secondary outcome measures included overall survival, overall response rate, complete response rate, and safety. CTI BioPharma, the manufacturer of pixantrone, did not report any specific data but intends to submit the PIX306 findings for publication in a peer-reviewed journal.

In 2012, single-agent pixantrone was approved in the European Union as a treatment for patients with relapsed/refractory, aggressive B-cell NHL. However, pixantrone has no approved indications in the United States.

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In diffuse large B-cell lymphoma, the combination of ibrutinib with standard R-CHOP did not improve event-free survival versus R-CHOP alone in the first-line setting for patients in the phase III DBL3001 trial. PFS was the primary endpoint of the trial.

While no data from the study were provided, AbbVie, which codevelops ibrutinib with Janssen Biotech, reported its intent to share the findings at an upcoming medical conference and publish them in a peer-reviewed journal.

The phase III DLB-3001 study included 838 patients with newly diagnosed DLBCL who had the non-germinal center B cell or activated B-cell subtypes of the disease. Patients were randomized to ibrutinib or placebo plus R-CHOP for 6 to 8 21-day cycles.

Early data showed promise that ibrutinib could improve outcomes with standard R-CHOP in patients with non-Hodgkin lymphoma. Specifically, the frontline combination was found to induce an objective response rate of 100% in patients with NHL in a small study presented at the 2013 ASCO Annual Meeting.

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This week, we sat down with Dr Susan M. O’Brien, of UC Irvine Health, to address unmet needs for the treatment of patients with chronic lymphocytic leukemia.

That’s all for today.

Thank you for watching OncLive News Network! I'm Gina Columbus.

SELECTEDLANGUAGE

Today-

An FDA approval in colorectal cancer, a priority review in hepatocellular carcinoma, encouraging findings in a multiple myeloma trial, and disappointing results in studies of diffuse large B-cell lymphoma and non-Hodgkin lymphoma.

Welcome to OncLive News Network! I'm Gina Columbus.

The FDA granted an accelerated approval to the combination of nivolumab and ipilimumab for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer following progression on a fluoropyrimidine, oxaliplatin, and irinotecan.

The decision is based on data from a cohort of 119 patients with MSI-H or dMMR mCRC treated with the combination in the phase II CheckMate-142 study. In this cohort, 82 patients received prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and the overall response rate was 46% among these patients.

Among the 38 responders, there were 3 complete responses and 35 partial responses. The median duration of response was not reached.

Among all 119 patients, the ORR was 49%. Among the 58 responders in the overall population, there were 5 CRs and 53 PRs. The median DOR was not reached, with 83% of responders having a response greater than or equal to 6 months and 19% having a response more than 12 months. Fifty-one of the 58 responses were ongoing at the data cutoff.

The accelerated approval of nivolumab/ipilimumab in this setting is contingent upon results from a confirmatory trial.

*********************************

The FDA has granted a priority review designation to a supplemental biologics license application for pembrolizumab for previously treated patients with advanced hepatocellular carcinoma.

The application is based on data from the phase II KEYNOTE-224 trial, in which single-agent pembrolizumab induced an overall response rate of 17% among 104 patients with advanced HCC who were previously treated with sorafenib. Among the 18 patients who responded, there was 1 complete response and 17 partial responses. Additionally, 46 patients had stable disease, 34 had progressive disease, and 6 patients were not evaluable.

Progressive disease and adverse events were found to be the most frequent cause of discontinuation with pembrolizumab. Post-progression therapy included cabozantinib in 1 patient and regorafenib in 20 patients.

Under the Prescription Drug User Fee Act, the FDA is scheduled to make a decision on the application by November 9, 2018.

In multiple myeloma, ixazomib was found to improve progression-free survival versus placebo as a maintenance therapy in adult patients who responded to high-dose therapy and autologous stem cell transplant, according to data from the phase III TOURMALINE-MM3 study.

Takeda Pharmaceutical Company, the manufacturer of the proteasome inhibitor, did not provide any specific data from the trial, but plans to submit the results for presentation at the 2018 ASH Annual Meeting.

In its press release, Takeda reported that there were no new safety signals with maintenance ixazomib, and toxicities were consistent with data from earlier studies of ixazomib monotherapy.

The FDA approved ixazomib in November 2015 for use in combination with lenalidomide and dexamethasone as a treatment for patients with multiple myeloma who have received at least 1 prior therapy. The decision was based on data from the phase III TOURMALINE-MM1 trial, which showed that adding ixazomib to lenalidomide and dexamethasone reduced the risk of disease progression or death by 26% versus lenalidomide and dexamethasone alone for patients with relapsed/refractory disease.

The PIX306 study enrolled 312 previously treated patients who received R-CHOP or equivalent treatment and relapsed. Patients were not eligible for stem cell transplant.

Beyond the primary PFS endpoint, secondary outcome measures included overall survival, overall response rate, complete response rate, and safety. CTI BioPharma, the manufacturer of pixantrone, did not report any specific data but intends to submit the PIX306 findings for publication in a peer-reviewed journal.

In 2012, single-agent pixantrone was approved in the European Union as a treatment for patients with relapsed/refractory, aggressive B-cell NHL. However, pixantrone has no approved indications in the United States.

*********************************

In diffuse large B-cell lymphoma, the combination of ibrutinib with standard R-CHOP did not improve event-free survival versus R-CHOP alone in the first-line setting for patients in the phase III DBL3001 trial. PFS was the primary endpoint of the trial.

While no data from the study were provided, AbbVie, which codevelops ibrutinib with Janssen Biotech, reported its intent to share the findings at an upcoming medical conference and publish them in a peer-reviewed journal.

The phase III DLB-3001 study included 838 patients with newly diagnosed DLBCL who had the non-germinal center B cell or activated B-cell subtypes of the disease. Patients were randomized to ibrutinib or placebo plus R-CHOP for 6 to 8 21-day cycles.

Early data showed promise that ibrutinib could improve outcomes with standard R-CHOP in patients with non-Hodgkin lymphoma. Specifically, the frontline combination was found to induce an objective response rate of 100% in patients with NHL in a small study presented at the 2013 ASCO Annual Meeting.

*********************************

This week, we sat down with Dr Susan M. O’Brien, of UC Irvine Health, to address unmet needs for the treatment of patients with chronic lymphocytic leukemia.